India: The Place Of Generics In A Product Patent Regime

The product patent regime in India fulfilled a long standing
need of the pioneer drug makers across the world wanting to
market their drugs in India but at the same time forced the
generic drug makers to stop their activities. Generic drugs
come cheaper in comparison to the patented drugs hence are
crucial to fulfill the gaps in access to medicines,
specifically the life saving drugs. This was anticipated
therefore flexibilities were provided in the TRIPS Agreement so
as to enable the Members to design their patent laws according
to their specific needs. The Indian patent law keeping in view
such flexibilities provides for compulsory licensing and
parallel import provisions. Examination of the use of such
flexibilities in context of affordable generic versions of
patented drugs will help to gain some insight into the future
of the generic industry and also on the issue of access to
drugs, in India.

Compulsory Licensing

Section 84 of the Patents Act 1970 provides for compulsory
licenses at any time after the expiration of three years from
the date of the grant of patent. The provision on compulsory
licensing can be invoked on following grounds –

The reasonable requirement of the public with respect to
the patented invention has not been satisfied;

The patented invention is not available to the public at
reasonably affordable price;

The patented invention is not worked in the territory of
India.

The bar of the expiry of three years may in some cases be
restrictive therefore as if to mitigate the risks, section 92
provides for compulsory licenses on notifications by Central
Government on the following grounds –

A circumstance of national emergency; or

A circumstance of extreme urgency; or

A case of public non-commercial use including public
health crises.

The mention of epidemics such as Acquired Immuno Deficiency
Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria
or like relating to the inclusive definition of public health
crises which in turn is explained as a case of public
non-commercial use under the provision amply reflects the use
of the flexibilities suitable to the Members as provided under
the TRIPS Agreement. The Patent (Amendment) Act 2005 added
another ground which provides for compulsory licenses to enable
export to countries with inadequate manufacturing capabilities.
Section 92 A reads as follows –

"Compulsory licenses shall be available for
manufacture and export of patented pharmaceutical products to
any country having insufficient or no manufacturing capacity in
the pharmaceutical sector for the concerned product to address
public health problems, provided compulsory license has been
granted by such country or such country has, by notification or
otherwise, allowed importation of the patented pharmaceutical
products from India."

>Parallel Import

Section 107A of the Patent Act, 1970 states certain acts not
to be considered as infringement wherein importation of
patented products by any person from a person who is duly
authorized under the law to produce and sell or distribute the
product is not an infringement. Thus, parallel import can also
be a tool for the generic industry to bridge the
'access' gap with regard to high priced drugs for
critical cures.

In conclusion we thus see that India has made a beneficial
use of the flexibilities which does pave a way for the generic
drug industry. Recently, not going by the rule book, CIPLA Ltd
launched its generic version of the drug patented by F.
Hoffman-La Roche Ltd which has consequently resulted in a
patent infringement suit filed by Roche and CIPLA
counterclaiming the invalidity of the granted
patent.1 The case is presently undergoing
preliminary hearings and CIPLA presumably will base its
strategy on the difference in pricing of the drugs. The
strategy of courting a litigation suit for establishing the
justifiability of 'access' is a new phenomenon for the
industry, which with bated breath watches every move of the
litigation process.

The Patents Act 1970, along with the Patents Rules 1972, came into force on 20th April 1972, replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala Ayyangar. One of the recommendations was the allowance of only process patents with regard to inventions relating to drugs, medicines, food and chemicals.

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